Tags: | SAMR | Food | Infant formula | 市场监管总局 | 食品 | 婴儿配方奶粉 |

I.        Introduction of Infant Formula CFDA Registration

On 1 October 2016, The Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes (Administrative Measures) outlines CFDA’s new registration requirements for domestic and foreign infant formula manufacturers, has beed taken into force. In accordance with these Administrative Measures, all infant formula brands exported to China must be registered with CFDA prior to 1 January 2018, after get the approval of CFDA then can be marketing in china.

Only infant formula milk powder production enterprises satisfying the following requirements can apply for infant formula products registration: with appropriate capabilities in research and development, production and inspection, satisfying the powdered infant formula foods’ good manufacturing practice requirements, having implemented the hazard analysis and critical control point system, the products are manufactured in accordance with relevant laws, carrying out batch testing of products produced in accordance with relevant legal provisions and items stipulated by infant formula milk powder food safety standards.

The Administrative Measures require each company in principle can only apply at most for nine formula products within three series, One series includes infant formula (0-6 months, 1 stage), older infant formula (6-12 months, 2 stage), and young children formula (12-36 months, 3 stage). The rules allow a wholly-owned subsidiary to use registered formula products of another wholly-owned subsidiary subordinated to a single group company.　

Foreign applicant need entrust a Chinese Responsibility Agent (CRA) to conduct the registration procedure, the CRA can be the foreign applicant china branch or other 3th part consulting company.

II.    Infant Formula CFDA Registration Timeline:

III.    Infant Formula CFDA Registration Cost:                                                      Curency:USD

IV.             Infant Formula CFDA Registration Application Documents List:

1.Application for Registration of Product Formula of Infant Formula Milk Powder;

2.Subject qualification certifications of the applicant;

3.Quality safety standard of raw materials and excipients;

4.Product formula;

5.Product formula R&D report;

6.Instruction for production process;

7.Product certificate of analysis; (Issued by CFDA designated Lab.)

8.Materials for certifying R&D capability, production capability and test capability;

9.Other materials indicating scientificity and safety of formula;

10.Label and package insert sample manuscript and the alleged instruction and certification documents.

V.  Infant Formula CFDA Registration Sample Test Items & GB standards:

At least test 3 batches products, and 1 batch Production site sampling when CFDA conduct site-audit.
The most time-consuming item is the stability test, usually need take 3-6 months.